Diabetes is a chronic, complex metabolic disease that results in the inability of the body to properly maintain and use carbohydrates, fats, and proteins. It results from the interaction of various hereditary and environmental factors and is characterized by high blood glucose levels caused by a deficiency in insulin production or an impairment of its utilization.
Diabetes is one of the leading public health problems in America today. As reported by the American Diabetic Association approximately 17 million people in the United States, or 6.2% of the population, has diabetes. Diabetes was the sixth leading cause of death listed on U.S. death certificates in 1999 accounting for 19 percent of all deaths that year. Of the 17 million of Americans who have diabetes, approximately 7 million, or 20.1 percent are 65 years of age and older. A staggering one million people are diagnosed with diabetes each year.
Many medical complications are the direct result of diabetes. Ocular complications such as diabetic retinopathy are the leading cause of new cases of legal blindness in people ages 20 to 74 in the United States. The risk for lower extremity amputation is 15 times greater in individuals with diabetes than in individuals without it. Kidney disease is a frequent and serious complication of diabetes. Approximately 30 percent of all new patients in the United States being treated for end-stage renal disease have diabetes.
The economic burden of diabetes is enormous. Each year patients with diabetes or complications from diabetes spend 50 million in-patient days in hospitals. A conservative estimate of total annual costs attributed to diabetes is at least $50 billion (American Diabetes Association estimate, 2002); however, the full economic impact of this disease is even greater because additional medical expenses often are attributed to the specific complications of the disease rather than to diabetes itself.
The risk of complications occurring in diabetics can be greatly reduced if the patient maintains good control of his/her blood glucose levels. Good control of blood glucose levels can be defined as having an adequate amount of insulin to utilize the amount of glucose in the body. Quantitatively, this blood glucose control is measured by determining the glycosylated hemoglobin level in patients over a two to three month period and is referred to as the determination of the patient's Hemoglobin A1c (HbA1c). The presence of glucose in the circulation results in a concentration dependent nonreversible covalent glycosylation of hemoglobin, forming hemoglobin sub-fractions A1a, A1b and A1c. Given the 120 day life span of the average human red blood cell, it is therefore possible to assess overall glucose levels in patients over the past two to three months by measuring the concentration of this glycosylated hemoglobin fraction A1c. The A1c fraction is based on the mathematical formula: % A1c=% GHb+1.76/1.49.
Reduction of glycemic or blood glucose concentrations in patients with diabetes mellitus prevents the development of diabetic complications. Currently, good blood glucose control is difficult to achieve in many patients with diabetes due to their inability to visually or cognitively perform the functions necessary to achieve optimum results. Examples of patients who are most at risk for complications because of poor blood glucose control are, but not limited to, the elderly, the very young, the visually or cognitively impaired and handicapped diabetics.
The obstacles that these patients encounter are endless. Among these obstacles are the proper administration of insulin dosages. Insulin is commonly delivered via syringes in specified doses during different intervals of time throughout the day. The current standard insulin syringe is clear, small, and utilizes incremental dosage markings that are very small and difficult to read. Diabetics with retinopathy and other ocular disorders have extreme difficulty seeing the small markings on the insulin syringe. Current remedies involve the enhancement of said markings, see for example, U.S. Pat. No. 720,381 (1903), for Hypodermic Syringe.
In patients with moderate to severe visual impairment the magnification or enhancement processes currently in use are often not an adequate solution to ensuring correct dosing. The ability to dispense medication at the proper time is another obstacle. Methods to store timed medication have been developed. Representative examples are seen in U.S. Pat. No. 1,650,980 (1927), for Case, U.S. Pat. No. 5,850,917 (1998), for syringe dosage tracking device with cooling feature, and U.S. Pat. No. 4,195,734 (1981), for apparatus for transporting medication and the like. Although these devices provide a suitable means for the storing and transporting of insulin, they are not designed to provide a safe and systematic approach for total diabetic management, especially for inpatients with limitations.
Often persons with insulin-dependent diabetes mellitus require several injections per day. In patients who have difficulty understanding directions or have visual impairment, caregiver intervention is required to ensure safe dosing. This requires that the caregiver be present to prepare each daily injection, which places extreme limitations on the caregiver as well as the patient. It often becomes necessary for the patient to live with a caregiver to accommodate the medication schedule, placing great burden on both the caregiver and patient. If professional health care is the only alternative available to the patient, the costs of frequent home visits to prepare medication is an enormous burden. It not only drains the lifetime limit on personal medical insurance, it becomes a major component of the problem of rising health care costs.
Patients with diabetes should not have to live their lives being dependent on others if options are available. Independent living and quality of life are vital components for the psychological, as well as economic, well-being of patients with diabetes mellitus.
A need therefore exists for an improved medication delivery method and apparatus.